Certification Reference Manual
Certification Program Reference Manual for Clinical Research Certification Examination
- The Nuremberg Code
- The Belmont Report
- The Declaration of Helsinki
- 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
- 45 U.S. Code of Federal Regulations - Part 46
- Sample regulatory forms from FDA
- ICH GCP Guideline for Good Clinical Practice (E6), and
- ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)
Note: Once a candidate's certification application is approved, a complimentary electronic copy of the reference manual will be sent.
Please complete the form below or click here to download a printable version of the Certification Program Reference Manual Print Request Form.